(88 days)
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with stress urinary incontinence.
The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of a wand and a hand-held controller. The Flyte wand is placed in the vagina and delivers a series of mechanical vibrations while the pelvic floor muscles are contracting. The hand-held controller controls the wand, guides the user through the treatment session and provides a visual feedback function to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand provides a resistive surface against which the user can contract the PFM, and houses an electric motor containing an eccentric weight that generates mechanical oscillations when the motor is running. A cable connects the wand and the controller.
The provided document [K233362] is a special 510(k) submission for a labeling modification to the Pelvital USA, Inc. Flyte System (aka Flyte System) (MTI-1.0). This means the device itself, its technological characteristics, and its principles of operation have not changed from its already cleared predicate device (K212655 Flyte System).
Therefore, this specific submission does not contain new acceptance criteria or a new study to demonstrate device performance. The document explicitly states: "Given the changes proposed in this submission were limited to minor labeling changes, no clinical and non-clinical performance data was submitted in this submission to support the changes."
To answer your questions, we would need the documentation associated with the original K212655 Flyte System clearance, which established the acceptance criteria and presented the performance study data that supported the substantial equivalence of the original device.
Without that original document, I can only provide general information based on the typical requirements for predicate devices.
Based on the information provided in K233362, the following answers apply:
1. A table of acceptance criteria and the reported device performance:
- No new acceptance criteria or reported device performance are presented in this submission. The submission is for a labeling modification only, indicating no changes to the device itself.
2. Sample size used for the test set and the data provenance:
- Not applicable to this submission. No new performance studies were conducted or presented. The original premarket notification (K212655) would contain this information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this submission. No new performance studies were conducted or presented.
4. Adjudication method for the test set:
- Not applicable to this submission. No new performance studies were conducted or presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable to this device. The Flyte System is a perineometer for strengthening pelvic floor muscles and does not involve AI or human readers evaluating medical images, which is typically where MRMC studies are performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable to this device. The Flyte System is a physical medical device, not an algorithm, and is intended for user-operated rehabilitative exercise, not an automated diagnostic or treatment system in the context of standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable to this submission. No new performance studies were conducted or presented. For the original device, performance would likely have been evaluated based on outcomes data related to pelvic floor muscle strengthening and reduction in stress urinary incontinence symptoms.
8. The sample size for the training set:
- Not applicable to this submission. No new performance studies were conducted or presented. This device does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable to this submission. As above, this device does not have a "training set" in the machine learning sense.
In summary, this document K233362 explicitly states that no new performance data was submitted because the submission is solely for a minor labeling modification, and the device itself is identical to its predicate (K212655). To obtain the requested information, you would need to review the original 510(k) submission for the K212655 Flyte System.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).